An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tanruprubart.
- Who it may be relevant to
- Registry conditions: Guillain-Barre Syndrome. Basic parameters: 12 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of a Single Dose of Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (GBS) (FORWARD Study)
Overview
The goal of this open label study is to measure pharmacokinetics, pharmacodynamics, early efficacy, and safety of tanruprubart in adult and pediatric participants, in the United States, Canada, and Europe.
Interventions
- Drug Tanruprubart
Solution for IV infusion.
Primary outcome measures
- Area Under the Tanruprubart Serum Concentration-time Curve to the Last Sample (AUC0-t) [Time frame: Up to Day 15]
- Observed Time to Maximum Observed Serum Concentration (Cmax) (Tmax) of Tanruprubart [Time frame: Up to Day 15]
Secondary outcome measures (2)
- Change From Baseline in Free Component of Complement Complex (C1q) Protein Concentration in Serum [Time frame: Baseline up to Day 15]
- Change from Baseline in Medical Research Council (MRC) Sumscore at Week 1 [Time frame: Baseline, Week 1]
Eligibility criteria
Inclusion criteria
- Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for GBS.
- Onset of GBS-related weakness ≤10 days before start of infusion on Day 1
- GBS-disability score (DS) score of 3, 4, or 5 at screening and before start of infusion on Day 1.
Exclusion criteria
- Previous or intended treatment with either plasma exchange or IV immunoglobulin for GBS.
- Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff's encephalitis, and overlap syndromes.
Other protocol-defined criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 12 centers
- St. Joseph's Hospital & Medical Center - Barrow Neurological Institute — Phoenix
- HonorHealth Bob Bové Neuroscience Institute — Scottsdale
- Profound Research LLC — Carlsbad
- Children's Hospital of Orange County — Orange
- University of California Irvine — Orange
- University of Colorado Hospital — Aurora
- Mayo Clinic Florida — Jacksonville
- University of Kansas Medical Center — Kansas City
- … and 4 more centers
Denmark · 1 center
- Aarhus University Hospital — Aarhus
Identifiers
NCT: NCT07020819 · ANX005-GBS-05 · 2025-522664-32-00